Kornimate/medical-research-clean huggingface dataset:
study evaluating inhaled aerolef (liposome-encapsulated fentanyl)in normal healthy subjects

Conditions: Healthy

Summary: this was a pilot, phase i, two-period, fasting, bioavailability, safety,and pharmacokinetic study evaluating single dose of i.v. fentanyl (200 µg) and single doses of 2 ml or 3 ml inhaled aerolef (500 µg/ml) delivered by nebulization with the aeroeclipse ban device administered in normal healthy non-smoking subjects.

in period i, subjects received an intravenous dose of fentanyl (200 µg) administered over 1 minute (treatment a). subjects then crossed over to period ii. in period ii, subjects were randomly assigned to receive either 2 ml (1000 µg fentanyl; treatment b) or 3ml (1500 µg fentanyl; treatment c) of aerolef delivered by nebulization with the aeroeclipse ban. subjects were instructed to continue inhalation of aerolef for approximately 1 minute beyond the point of nebulizer sputter to ensure that all aerosolized medication was delivered. there was at least a 1 week washout period between study periods.

Eligibility criteria:
inclusion criteria: * non-smoking male or female with a minimum age of at least 18 years * body weight with abmi range of 18.5 - 27, with a minimum weight of at least 60 kg. * availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, written, informed consent form. * normal findings in the physical examination, vital signs (blood pressure between 100-140 - 60-90 mmhg, heart rate between 55-99 beats/min, respiration rate between 12-20 minute) and a 12 lead ecg. * negative for drug abuse, nicotine, alcohol, hepatitis b-surface antigen, hepatitis c and hiv. * if a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline. * no clinical laboratory values outside of the principal investigator's acceptable range, unless the principal investigator decided that the subject's values are not clinically significant. * female subjects: (a) if pre-menopausal, have regular menstrual cycles (28-32 days), and (b) are not pregnant prior to study start and avoids pregnancy during the study and 1 month post drug administration, or (c) were surgically sterile for at least 6 months prior to enrollment, or (d) are post-menopausal for at least 1 year prior to enrollment. exclusion criteria: * known history of hypersensitivity to fentanyl. * presence or history of cardiac, pulmonary, gastrointestinal, endocrine, neuromuscular, neurologic, hematological, liver or kidney disease, or any condition known to interfere with absorption, distribution , metabolism, or excretion of drugs. * history of drug abuse or narcotic dependency. * use of prescription medication within 30 days preceding entry int the study, including any enzyme inducing/inhibitory drugs (excluding contraceptives). * participating in a clinical trial with an investigational drug within 30 days preceding this trial. * blood donation within 45 days preceding this trial.

Keywords: aerolef fentanyl pharmacokinetic liposome encapsulated
ntraperitoneal thermal perfusion combined with chemotherapy versus chemotherapy

Conditions: Advanced Pancreatic Cancer

Summary: in view of the existence of malignant ascites in patients with advanced pancreatic cancer, we put forward the heat abdominal cavity perfusion chemotherapy combined albumin paclitaxel and gemcitabine compared with albumin paclitaxel and gemcitabine prospective clinical study, to assess abdominal albumin hot perfusion chemotherapy combined control of ascites and taxol in improving patients' quality of life, survival, exploring the feasibility of celiac hot perfusion chemotherapy combined albumin paclitaxel and side effects.


Eligibility criteria:
inclusion criteria: * participate voluntarily and sign informed consent; * age ≥18 years old and ≤80 years old, regardless of gender; * physical condition ecog 0 \~ 2; * the diagnosis of pancreatic adenocarcinoma was confirmed by pathology; * peritoneal metastasis was confirmed by ascites cytology, or was pathologically confirmed by surgical exploration and biopsy; * expected survival ≥3 months; * no serious abnormal blood system, heart and lung function and immune deficiency (refer to respective standards); * blood routine indicators: white blood cell (wbc) ≥3 × 109/l;absolute count of neutrophils (anc) ≥1.5 × 109/l;platelet (plt) ≥100 × 109/l;hemoglobin (hgb) ≥9 g/dl; * blood biochemical indexes: ast (sgot) and alt (sgpt) ≤2.5 × upper limit of normal value (uln);total bilirubin (tbil) ≤uln;serum creatinine (cre) ≤1.5 × uln; * coagulation function: prothrombin time (pt), international standard ratio (inr) ≤1.5 × uln; * comply with the study visit plan and other program requirements. exclusion criteria: * accompanied by other systemic malignant tumors; * received any form of anti-tumor therapy, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, tumor palliative resection and molecular targeted therapy; * used any other study drugs within 5 weeks before enrollment; * central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled; * uncontrolled infection, bleeding, pancreatic leakage, bile leakage, or other postoperative complications during baseline examination;acute and chronic metabolic acidosis (including ketoacidosis and lactic acidosis) has not been corrected. * a history of allergy to study drugs or similar structured drugs; * pregnant or lactating women; * any conditions, including serious medical risk factors, medical conditions, and laboratory abnormalities, that may impair patient safety or the integrity of research data; * intestinal obstruction, extensive adhesion in the peritoneal cavity, abdominal inflammation, etc.
lurasidone hcl: a phase 3 study of patients with acute schizophrenia

Conditions: Schizophrenia

Summary: lurasidone hcl is a compound being developed for the treatment of schizophrenia. this clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. the study will also evaluate the safety and tolerability of lurasidone as compared to placebo.


Eligibility criteria:
inclusion criteria: to be eligible to enter the study, each patient must comply with the following inclusion criteria: * provide written informed consent and aged between 18 and 75 years of age. * meets dsm-iv™ criteria for a primary diagnosis of schizophrenia. * not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study. * able and agrees to remain off prior antipsychotic medication for the duration of study. * good physical health on the basis of medical history, physical examination, and laboratory screening. * willing and able to comply with the protocol, including the inpatient requirements and outpatient visits. exclusion criteria: * considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. * any chronic organic disease of the cns (other than schizophrenia) * used investigational compound within 30 days. * clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

Keywords: schizophrenia sm-13496 latuda lurasidone
outcome of high dose vitamin d on prognosis of sepsis requiring mechanical ventilation

Conditions: Sepsis

Summary: there is a high prevalence of vitamin d deficiency in the critically ill patient population, with approximately 60% of patients found to be vitamin d deficient, (25(oh)d concentrations \<20 ng/ml) and an additional 30% of patients being vitamin d insufficient, (25(oh)d = 20-30 ng/ml).approximately 80% of sepsis/septic shock patients experience respiratory failure and require mechanical ventilation. furthermore, several studies document that vitamin d deficiency could be associated with poor outcomes in critically ill patient.


Eligibility criteria:
inclusion criteria: * diagnosed with sepsis and required mechanical ventilation (mv) within 24 hours from icu admission. * expected to require mechanical ventilation for at least 72 hours after study entry. exclusion criteria: * age \<18 years. * inability to obtain informed consent from the patient and/or legally authorized representative. * bmi\> 40. * pregnant or breastfeeding. * chronic kidney diseases * pancreatitis. * hepatic insufficiency * cases with coagulopathy * moribund and not expected to survive 96 hours. * ongoing shock * history of therapy with high dose vitamin d3 within previous 6 months. * history of disorders associated with hypercalcemia * cancer as the cause of sepsis. * subjects undergoing chemotherapy. * immune compromised patients. * pneumonia developed \< 48 hours following intubation. * patients with history of aspiration before intubation. * known allergy to vitamin d.
a communication tool to improve communication in the icu

Conditions: Serious Injury; Communication

Summary: the purpose of this study is to test the effectiveness of the best case/worst case-icu communication tool on quality of communication, clinician moral distress, and icu length of stay for older adults with serious traumatic injury. investigators will follow an estimated 4500 patients aged 50 years and older who are in the icu for 3 or more days and survey 1500 family members and up to 1600 clinicians from 8 sites nationwide.

this is a multisite, stepped-wedge, randomized clinical trial. at the start of the study, investigators will randomly assign each site to the time when the intervention team will train all trauma surgeons, trainees, and icu clinicians to use the best case/worst case-icu tool. participants in the intervention group will receive care from a trauma team that routinely uses the best case/worst case-icu communication tool. participants in the control group will receive usual care. the study team will follow an estimated 4,500 patients with the highest post-injury mortality: aged 50 years and older with an icu length of stay of 3 or more days. they will administer surveys to family members (quality of communication) and clinicians (moral distress) and obtain patient-level outcomes (icu length of stay (los)), clinical data, and demographics from the trauma quality improvement program (tqip) national registry. objectives: * aim 1: to test the effectiveness of the best case/worst case-icu communication tool on improving the quality of communication in the trauma icu. * aim 2: to test the effectiveness of the best case/worst case-icu communication tool on reducing clinician moral distress in the icu. * aim 3: to test the effectiveness of the best case/worst case-icu communication tool on reducing icu length of stay.

Eligibility criteria:
patients inclusion criteria: * aged 50 and older * admitted to the icu for 3 or more days after serious injury exclusion criteria: * none family members inclusion criteria: * aged 18 and older * patient's family member or informally designated "like family" or primary surrogate decision maker * speak english or spanish exclusion criteria: * does not have decision-making capacity clinicians inclusion criteria: * provide care in the trauma icu (including attending trauma surgeons, fellows, residents, advance practice providers, bedside nurses and medical assistants, respiratory techs and physical therapists, social workers, and chaplains) exclusion criteria: * do not provide care in the trauma icu

Keywords: intensive care unit trauma patient decision making surgical decision making shared decision making decision support techniques
short and long term outcomes of acute coronary syndrome in patients with non obstructive coronary atherosclerosis

Conditions: Acute Coronary Syndrome

Summary: the purpose of the study is to assess short and long term outcomes of acute coronary syndrome in patients with non obstructive coronary atherosclerosis, to optimize the algorithm for diagnosis and to evaluate its effectiveness

the study non randomized, opened, controlled. cardiovascular magnetic - resonance imaging reveals both ischemic and non-ischemic causes of acute coronary syndrome. currently, it is the best method for imaging and damage assessment of myocardial viability in coronary atherosclerosis and noncoronary injuries (v.yu.usov 2012). taking into account the results of previous (d. kawecki, b. morawiec, p. monney, 2015) research, it can be concluded that the introduction of cardiovascular magnetic resonance imaging into routine practice will change the structure of morbidity among patients with acute coronary syndrome and non obstructive coronary atherosclerosis . the research was conducted on small groups of patients, and therefore further data acquisition is required. it is planned to study 200 patients with acute coronary syndrome. on admission, they will receive the standard treatment of acs with and without st elevation. within 72 hours they will performed diagnostic coronary angiography. if in case of non stenotic atherosclerosis of coronary artery (normal / stenosis \< 50%) patients are planned for cardiac contrast mri, which will identify both ischemic and non-ischemic causes of acute coronary syndrome. at 30 days, 6 months, 12 months the researchers will assess the clinical condition of the patients, perform cardiac ultrasound for the evaluation of myocardial contractile function, evaluate the incidence rate of secondary endpoints

Eligibility criteria:
inclusion criteria: * age ≥ 18 years at time of randomization (18 years and older) * acute coronary syndrome * no obstructive coronary atherosclerosis (normal coronary artety/ plaques \<50%) is based on the results of coronary angiography for 3 days of admission * written the informed consent to participate in research exclusion criteria: * patients previously undergone endovascular / surgical revascularization of coronary artery * severe comorbidity * contacts/locations

Keywords: acs non obstructive coronary atherosclerosis
magnesium administration after cardioplegic arrest with del nido cardioplegia

Conditions: Del Nido Cardioplegia

Summary: the cardioplegia solution of choice in many pediatric cardiac congenital programs is the del nido solution. while many cardioplegia solutions provide diastolic arrest, del nido provides a longer period of time between doses of cardioplegia. many of the other cardioplegia solutions do not incorporate magnesium into the constituents, but del nido does. routine practice at cchmc is to dose 25 mg/kg magnesium upon removal of the heart cross-clamp to protect against hypomagnesemia and associated arrhythmias. however, with the incorporation of magnesium in the del nido solution, it may not be necessary to administer magnesium post cross-clamp and it could in fact be detrimental if the magnesium level is too high. this observational study will examine the magnesium levels prior to and after cross-clamp removal under our current process. the magnesium levels measured after the administration of del nido cardioplegia and prior to cross-clamp removal will help inform our current practice.


Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery requiring cpb and cardioplegic arrest with del nido cardioplegia solution. * patients planned to receive post cross-clamp dose of 25 mg/kg magnesium sulfate.
radiofrequency ablation for gastric metaplasia and dysplasia

Conditions: Gastric Dysplasia; Intestinal Metaplasia

Summary: gastric intestinal metaplasia (im) and dysplasia, also referred to as intra-epithelial neoplasia, are well recognized precursors of gastric cancer. apart from endoscopic surveillance, there is no other intervention which predictably eradicates pre-cancerous gastric lesions. endoscopic radiofrequency ablative (rfa) therapy has been recently shown to be highly effective in eradicating both im and dysplasia in patients with barrett's esophagus. however, the potential role of rfa to remove gastric im and dysplasia remains unknown. in this study, we determine the feasibility of using endoscopic rfa in treating early gastric neoplasia (metaplasia and dysplasia). patients with gastric metaplasia and/or dysplasia will be treated with endoscopic rfa. the safety and effects of rfa will be determined.


Eligibility criteria:
inclusion criteria: 1. histological confirmation of gastric im or dysplasia. 2. the lesion is no larger than 5 cm in diameter. 3. age ≥ 18 years. 4. no previous endoscopic mucosal resection or submucosal dissection. 5. no active h. pylori infection. 6. subject is able to tolerate endoscopy and sedation. 7. subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form. exclusion criteria: 1. gastric cancer (intra-mucosal cancer or worse). 2. prior gastric irradiation or surgery. 3. anti-platelet or anti-thrombotic medication use that cannot be stopped for 7 days before and after rfa. 4. gastric ulcers, fistulae and varices. 5. history of alcohol and/or controlled substance dependency. 6. pregnancy.
a measurement of knee osteoarthritis usual care

Conditions: Osteoarthritis, Knee; Guideline Adherence; Quality Indicators, Health Care

Summary: osteoarthritis is the most common affection of joints worldwide. multiple international guidelines on the approach and treatment of knee osteoarthritis are available. nevertheless there seems to be a gap between usual care and the preferred one. a vigorous set of evidence-based quality indicators on osteoarthritis diagnosis and therapy was developed by a multidisciplinary expert team. this project aims to map usual care and to explore the gaps between usual care and international guidelines in a second stage. this will enable us to develop a tightly targeted quality improvement intervention later on.


Eligibility criteria:
inclusion criteria: * diagnosis of knee osteoarthritis exclusion criteria: * knee replacement surgery * acute trauma (recruitment by orthopedic surgeons)
characteristics of infective endocarditis in east china

Conditions: Infective Endocarditis

Summary: this was a retrospective observational study of consecutive cases of definite or possible infective endocarditis (ie) as per the modified duke criteria between january 2008 and december 2015, which was performed at the second affiliated hospital of zhejiang university, school of medicine (sahzu), a tertiary care referral hospital located in east china.

infective endocarditis (ie) is a rare but life-threatening serious disease that still has a high mortality, even in developed countries. the objective of this study was to evaluate the clinical presentations, treatment and outcomes of ie patients in a tertiary hospital in east china over an 8-year period. this was a retrospective observational study of consecutive cases of definite or possible ie as per the modified duke criteria between january 2008 and december 2015.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of infective endocarditis. exclusion criteria: * patients did not meet the modified duke criteria.
overactive bladder telemedicine non-inferiority trial

Conditions: Overactive Bladder

Summary: in this study, the investigators aim to validate the telemedicine paradigm as a feasible alternative to traditional in-person clinic visits for the management of overactive bladder (oab).

this is a single-center, prospective randomized controlled trial. the study population will consist of two primary cohorts stratified based on the method of follow-up, either traditional in-person clinic visit or telemedicine appointment. the primary outcome will be satisfaction with oab treatment. secondary endpoints include rate of progression to third line therapies, changes in oab symptom scores, safety, and cost. this non-inferiority trial is designed to provide an alternative option for care delivery that may result in improved patient satisfaction and compliance, and decreased cost, time, and travel burden for patients.

Eligibility criteria:
inclusion criteria: * idiopathic overactive bladder diagnosis, both oab wet and oab dry exclusion criteria: * active urinary tract infection (uti) * stage 3 or 4 prolapse * underlying neurologic condition contributing to oab * use of catheter
an open-label study of xoma 358 in patients with hypoglycemia after gastric bypass surgery

Conditions: Hypoglycemia

Summary: the purpose of this study is to evaluate the safety and clinical pharmacology of xoma 358 in patients with hypoglycemia after gastric bypass surgery.


Eligibility criteria:
inclusion criteria: * aged at least 18 years of age * body mass index \< 35 kg/m2 at baseline, unless discussed with medical monitor and patients with higher body mass index do not have significant medical co-morbidities that would confound ability to assess safety and efficacy of study drug. * received gastric bypass surgery more than 1 year before dosing * occurrence of postprandial hypoglycemia (blood glucose less than 60mg/dl) during the baseline provocation assessments and/or by continuous glucose monitoring, as defined in the protocol. exclusion criteria: * history of type 1 diabetes * planned use of the following medications on or after day -3 (part 1): * any agent for hypoglycemia, such as diazoxide or octreotide * antihyperglycemic agents, including subcutaneous insulin therapy, sulfonylureas, sglt2 inhibitors, and glp-1 agonists * systemic glucocorticoids or β agonists that may affect glucose metabolism * long-acting somatostatin analogs or glucose-affecting medications * during part 2, the following therapies are prohibited as specified below: * tramadol and any other medications not used in the treatment of post-bariatric surgery hypoglycemia that may cause hypoglycemia or fluctuations in blood glucose levels. * acetaminophen-containing products during periods of continuous glucose monitoring. medications such as tramadol may cause hypoglycemia or fluctuations in blood glucose levels and, as such, use of such medications is subject to the restrictions as described above during the study. acetaminophen can interfere with the accuracy of the glucose sensor of the continuous glucose monitoring system and is, therefore, prohibited during continuous glucose monitoring. * major general surgery within 3 months before study entry or anticipated during the study period other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypoglycemia
als research collaborative

Conditions: Amyotrophic Lateral Sclerosis; ALS (Amyotrophic Lateral Sclerosis); ALS With Frontotemporal Dementia (ALS/FTD); Motor Neuron Disease; Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Summary: the goal of this natural history study is to learn more about the biological and clinical aspects of amyotrophic lateral sclerosis (als). this study's findings will help with drug discovery, biomarker discovery, and outcome measure validation. adults living with als, other motor neuron diseases (mnd), a known mutation related to als and healthy volunteers contribute prospective and retrospective data to this study remotely. the study is sponsored and conducted by the als therapy development institute.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * can communicate in written english * has a diagnosis of als/mnd or is a known carrier of an als associated mutation exclusion criteria: * significant cognitive impairment that would prevent individual completion and understanding of the informed consent process.

Keywords: arc als research collaborative als tdi als therapy develeopment institute